Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines)
Table of contents
Date:
18/11/2019 to 19/11/2019
Location:
European Medicines Agency, Amsterdam, the Netherlands
The European Medicines Agency (EMA)'s multi-stakeholder workshop on itsRegulatory science strategy strategy for:
- sharing the outcome and key messages from the analysis of the public consultation on the strategy;
- reflecting on the likely prioritisation of core recommendations;
- identifying concrete actions in order to implement the key goals and core recommendations, addressing expertise development and process evolution.
The participants include patient representatives, healthcare professionals, academia, health technology assessment bodies, payers organisations, trade associations and regulators.
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Agenda - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines) (PDF/524.5 KB)
First published: 11/11/2019
Last updated: 14/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Welcome (PDF/462.51 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Overview of the outcome of the publication consultation (PDF/1.2 MB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Support developments in precision medicine, biomarkers and ‘omics’ (PDF/388.12 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Support translation of advanced therapy medicinal products (ATMPs) into patient treatments (PDF/513.79 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products (PDF/381.1 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Diversify and integrate the provision of regulatory advice along the development continuum (PDF/397.11 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Recommendations related to downstream decision making, HTA’s preparedness, and collaboration with payers (PDF/793.84 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Promote use of high-quality real-world data (RWD) in decision making (PDF/408.29 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Foster innovation in clinical trials (PDF/388.69 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Develop the regulatory framework for emerging clinical data generation (PDF/647.75 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Optimise capabilities in modelling, simulation and extrapolation (PDF/461.88 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Reinforce patient relevance in evidence generation (PDF/569.3 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science (PDF/581.18 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Developing scientific advice/assessment pathways - Feedback from breakout session 3A (PDF/571.1 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Optimising evidence incl. RWD for decision making and communication - Feedback from session 3B (PDF/334.62 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Continue to support development of new antibacterial agents and their alternatives (PDF/560.1 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Support innovative approaches to the development, approval and post-authorisation monitoring of vaccines (PDF/383.93 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Reinforcing patient relevance in evidence generation - Feedback from breakout session 5C (PDF/313.25 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Developing research partnerships with academia - Feedback from breakout session 5D (PDF/425.19 KB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Delivering the strategy (PDF/1.32 MB)
First published: 26/11/2019 -
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Presentation - EMA Regulatory Science to 2025 - Human Workshop - Draft briefing materials (PDF/734.81 KB)
First published: 26/11/2019
